Safety Of Procedural Sedation Research Articles

Safety of procedural sedation in emergency department settings among the adult population: a systematic review and meta-analysis of randomized controlled trials.

Procedural sedation and analgesia (PSA) are a common practice in emergency departments (EDs), aiming to alleviate pain, anxiety, and discomfort during various medical procedures. We have undertaken a systematic review and meta-analysis with the aim of assessing the incidence of adverse events associated with PSA, including those related to individual drugs and various drug combinations. The study adhered to PRISMA guidelines for a systematic review and meta-analysis of adverse events in ED sedation. A comprehensive search strategy was employed across ten databases, supplemented by searches on clinicaltrials.gov and manual reviews of reference lists. Data extraction focused on medication administration and adverse events. The study considered four types of adverse events: cardiac, respiratory, gastrointestinal, and neurological. Only randomized controlled trials (RCTs) focusing on PSA administered to adult patients within the ED setting were included. The statistical analysis employed OpenMeta Analyst to conduct a one-arm meta-analysis, with findings presented alongside their corresponding 95% Confidence Intervals. Forest plots were constructed to combine and evaluate results, and sensitivity analyses were performed to identify sources of heterogeneity. From a literature search of 4246 records, 32 RCTs were deemed suitable for this meta-analysis. The analysis included 6377 procedural sedations. The most common adverse event was hypoxia, with an incidence rate of 78.5 per 1000 sedations (95% CI = 77.5-133.5). This was followed by apnea and hypotension, with incidence rates of 31 (95% CI = 19.5-41.8) and 28.1 (95% CI = 17.4-38.9) per 1,000 sedations, respectively. Agitation and vomiting each occurred in 15.6 per 1,000 sedations (95% CI = 8.7-22.6). Severe adverse events were rare, with bradycardia observed in 16.7 per 1,000 sedations, laryngospasm in 2.9 per 1,000 sedations (95% CI = - 0.1 to 6), intubation in 10.8 per 1,000 sedations (95% CI = 4-17), and aspiration in 2.7 per 1,000 sedations (95% CI = - 0.3 to 5.7). Ketamine is found to be the safest option in terms of respiratory adverse events, with the lowest rates of apnea and hypoxia, making it the least respiratory depressant among the evaluated drugs. Etomidate has the least occurrence of hypotension when used alone. Propofol has the highest incidence of hypotension when used alone and ranks second in hypoxia-related adverse events after midazolam. Using combinations of sedating agents, such as propofol and ketamine, has been found to offer several advantages over single drugs, especially in reducing adverse events like vomiting, intubation difficulty, hypotension, bradycardia, and laryngospasm. The combination significantly reduces the incidence of hypotension compared to using propofol or ketamine individually. Despite the regular use of procedural sedation, it can sometimes lead to serious adverse events. Respiratory issues like apnea and hypoxia, while not common, do occur more often than cardiovascular problems such as hypotension. However, the least frequent respiratory complications, which can also pose a threat to life, include laryngospasm, aspiration, and intubation. These incidents are extremely rare.

Anxiety of parents and children undergoing gastrointestinal endoscopy correlates with sedative doses

Aim: Sedation is a fundamental component of the pediatric gastrointestinal endoscopy (GIE). The dosing of drugs to be used for sedating the child is an important aspect of the efficacy and safety of procedural sedation. Besides, outpatient procedures are stressful situations for pediatric patients and also their families, and therefore, parental anxiety may affect children indirectly. The first aim of the study was to assess the association between parental anxiety and required sedative dose in children undergoing GIE. The second aim was to assess the factors associated with children’s preoperative anxiety. 
 Material and Method: This study was a prospective, observational, and single-center study performed by the same fellowship-trained pediatric gastroenterology specialist and the same anesthesiology specialist. Parental anxiety was evaluated with the State-Trait-Anxiety-Scale (STAI) and children's anxiety was evaluated with the Modified Yale Preoperative Anxiety Scale (mYPAS). Midazolam, ketamine, propofol, and fentanyl were administered for the children’s sedation. There were 2 comparisons in this study, the anxiety of parents according to mean STAI scores, and anxiety of children according to mYPAS scores. 
 Results: Of 120 children and parents, 87 parents (73%) and 57 children (48%) had high anxiety. Of 120 parents, 111 parents (92%) were mothers of the children. Younger children had higher anxiety levels. Before and the start of the GIE heart rates of children were higher both in the high anxiety group of parents and children. In sedatives, high anxiety parents’ children and high anxiety children were required more ketamine dosages. (p

Efficacy and safety of the combination of propofol and S(+)-ketamine for procedural sedation in pediatric patients undergoing totally implantable venous access port implantation: A prospective randomized controlled study.

BackgroundTotally implantable venous access port (TIVAP) implantation is usually performed under general anesthesia with endotracheal intubation in children. Procedural sedation without endotracheal intubation has been applied to minor pediatric surgeries like central venous catheter insertion. To explore a more efficient and less invasive anesthesia mode to implant TIVAPs for children, we aimed to evaluate the efficacy and safety of procedural sedation using propofol and S(+)-ketamine compared with general anesthesia.MethodsSixty-six patients aged 6 months to 10 years undergoing TIVAP implantation were randomly allocated to two groups. Patients under procedural sedation [S(+)-ketamine-propofol (sketofol) group] were given target-controlled infusion of propofol 4 μg/ml using the Paedfusor model and S(+)-ketamine 0.5 mg/kg as induction, and had target-controlled infusion of propofol 3–4 μg/ml as maintenance. Patients in sketofol group received medium-flow oxygen inhalation through facemasks during surgery. Patients under general anesthesia (control group) were given propofol 2 mg/kg, cisatracurium 0.2 mg/kg, fentanyl 3 μg/kg as induction, and sevoflurane 0.8 minimum alveolar concentration as maintenance after endotracheal intubation. Primary outcome was the postoperative emergence agitation evaluated 5 min after awakening.ResultsPostoperative emergence agitation evaluated 5 min after awakening was lower in sketofol group versus control group [1.0 (0.5, 1.0) vs. 3.0 (2.0, 4.0); median difference (95% CI): 2.0 (1.0, 2.0); P < 0.001]. Time to awakening was significantly lower in sketofol group versus control group [15.0 (5.0, 23.0) vs. 26.0 (20.5, 37.5); median difference (95% CI): 11.0 (7.0, 19.0); P < 0.001], as well as time to discharge from post anesthesia care unit [35.0 (24.0, 45.0) vs. 45.0 (37.5, 59.5); median difference (95% CI): 10.0 (10.0, 23.0); P < 0.001]. Postoperative complications or adverse events were not reported in sketofol group.ConclusionsCompared to general anesthesia with endotracheal intubation, procedural sedation using propofol and S(+)-ketamine improves the postoperative emergence agitation right after the recovery of consciousness, and has advantage in shortening anesthetic recovery time for pediatric patients undergoing TIVAP implantation.

Procedural Sedation With Dexmedetomidine in Combination With Ketamine in the Emergency Department

BackgroundDexmedetomidine is an alternative agent for procedural sedation in the emergency department thanks to its ability to maintain hemodynamic and respiratory stability. Dexmedetomidine must, however, be combined with a powerful analgesic. ObjectiveOur aim was to evaluate the quality and safety of procedural sedation using the combination of dexmedetomidine and ketamine for patients undergoing painful procedures in the emergency department. MethodsThis prospective interventional single-center study was conducted in an academic emergency department of an urban hospital in Brussels, Belgium. Patients received a bolus injection of 1 µg/kg dexmedetomidine over 10 min and then a continuous infusion of 0.6 µg/kg/h followed by a bolus of 1 mg/kg ketamine. The painful procedure was carried out 1 min later. The level of pain was evaluated with a numerical rating scale from 0 (no pain) to 10 (maximal pain). The level of patient comfort for the procedure was measured using a comfort scale. ResultsThirty patients were included. Overall, 90% of patients felt little or no pain (n = 29 of 30) or discomfort (n = 28 of 30) during the procedure. One patient experienced apnea with desaturation, which was resolved by a jaw-thrust maneuver. Although 23% of patients had significant arterial hypertension, none required drug treatment. ConclusionsThe combination of dexmedetomidine and ketamine provides conscious sedation, bringing comfort and pain relief to patients in optimal conditions for respiratory and hemodynamic safety. However, sedation and recovery times are longer than with conventional drug combinations. The dexmedetomidine–ketamine combination should therefore be recommended for nonurgent procedures and fragile patients.

Service Evaluation of the Impact of Capnography on the Safety of Procedural Sedation.

BackgroundCapnography has been associated with a reduced incidence of events related to respiratory compromise during procedural sedation.MethodsA prospective service evaluation was conducted at a large United Kingdom (UK) teaching hospital to assess the impact of capnography on patient safety within four speciality services: bronchoscopy, endoscopy, interventional cardiology, and interventional radiology. Events were defined as provided by the World Society of Intravenous Anaesthesia. One thousand four hundred one patients were enrolled in the evaluation, with 666 patients before and 735 after implementation of capnography. Data was entered as a convenience sample on site in an offline data-collection tool. Results were assessed for the relative reduction in the incidence and resulting adjusted odds ratio for the combined incidence of oxygen desaturation (75–90% for <60s), severe oxygen desaturation (<75% at any time) or prolonged oxygen desaturation (<90% for >60s), bradycardia (>25% from baseline) and tachycardia (>25% from baseline). The adjusted odds ratio was controlled for both procedure and patient characteristics.ResultsAfter implementation of capnography, a significant reduction (43.2%, p ≤ 0.05) in adverse events was observed: 147 adverse events occurred during 666 procedures without capnography compared with 93 adverse events that occurred during 735 procedures with capnography. The adjusted odds ratio for the occurrence of the target adverse events was 0.57 (95% CI: 0.42–0.77). Multivariable linear regression indicated that capnography was a significant predictor (p 0.001) of reduced adverse events.ConclusionThese results suggest improved patient safety following capnography implementation.

Safety of Procedural Sedation in Pregnancy

AbstractMinor traumatic injuries are common in pregnancy, often subsequently requiring painful diagnostic and therapeutic procedures. Pregnant women who are experiencing significant pain, distress, or fear may benefit from procedural sedation in the emergency department. In this review we examine the fetal safety of specific drugs used for procedural sedation.

Efficacy and Safety of Procedural Sedation and Analgesia for Burn Wound Care

The study aim was to quantify efficacy and patient safety of registered nurse-administered procedural sedation and analgesia in a regional burn center. The investigators conducted a review of procedural sedation forms for all pediatric and adult patients admitted to this burn center from January 1, 2005, through December 31, 2005, for demographic and clinical data including patient age, gender, body weight, TBSA, dates of burn injury and wound care procedures, length of procedure, pre- and postprocedural pain assessment, procedural sedation/analgesia medications and doses, adverse drug events, and related interventions. During the 12-month study period, a total of 328 burn patients received 1293 procedural sedation procedures; child subjects (≤ 18 years) received 356 procedures and adult subjects (19-87 years) received 937 procedures. The mean (SD) length of the procedure was 60.1 (22.49) minutes with a range of 10 to 170 minutes. The mean subject age was 34.2 years (range: 6 weeks to 87 years), 67% were male, and the mean TBSA was 17% (0.5-68%). Ninety-four percent received fentanyl for analgesia and 85% received midazolam for anxiolysis and amnesia. The mean preprocedural pain score was 3.2 and the mean postprocedural pain score was 2 (t = 14.795; df = 1243; P < .001). Ten adverse events, all respiratory related, were documented in eight patients, two of whom experienced a second adverse event for an overall adverse event rate of 0.77%. No patient required intubation. Procedural sedation administered by a registered nurse competent in administration and monitoring in a burn center provided safe and effective pain management during wound care.

Safety and efficiency of procedural sedation and analgesia (PSA) conducted by medical officers in a level 1 hospital in Cape Town.

To study the efficacy and safety of procedural sedation and analgesia (PSA) administered by medical officers (MOs) without formal anaesthetic training. A retrospective descriptive study in the Emergency Department (ED) of False Bay Hospital (FBH), situated in the southern suburbs of the Cape Town Metro Health District. The study included all patients who received PSA at FBH between 1 March 2007 and 31 August 2009. Variables recorded included age, gender, physical status as determined by the American Society of Anesthesiologists (ASA status), procedure, fasting and intoxication status, PSA medications, adverse effects, rescue manoeuvres performed, if any, and time to discharge. Analysis was largely descriptive and clinical and demographic data are presented as means (standard deviations), medians, ranges and proportions as appropriate. Success of sedation and incidence of adverse effects are presented as proportions. Of 166 patients, 140 (84.3%) showed a good level of sedation, 14 (8.4%) were inadequately sedated, 5 (3%) were too deeply sedated but showed no signs of respiratory compromise, and 7 (4.2%) developed respiratory side-effects. Respiratory complications were treated with simple airway manoeuvres; no patient required intubation or experienced respiratory problems after waking up. There was no significant difference in the risk of adverse effects between the fasted and non-fasted groups. Mildly intoxicated patients who received PSA were at a higher risk of adverse effects. PSA can be administered safely by medical officers. Future research should expand on PSA research in this setting and focus on safety and patient satisfaction.

Professional Skills and Competence for Safe and Effective Procedural Sedation in Children: Recommendations Based on a Systematic Review of the Literature

Objectives. To investigate which skills and competence are imperative to assure optimal effectiveness and safety of procedural sedation (PS) in children and to analyze the underlying levels of evidence. Study Design and methods. Systematic review of literature published between 1993 and March 2009. Selected papers were classified according to their methodological quality and summarized in evidence-based conclusions. Next, conclusions were used to formulate recommendations. Results. Although the safety profiles vary among PS drugs, the possibility of potentially serious adverse events and the predictability of depth and duration of sedation define the imperative skills and competence necessary for a timely recognition and appropriate management. The level of effectiveness is mainly determined by the ability to apply titratable PS, including deep sedation using short-acting anesthetics for invasive procedures and nitrous oxide for minor painful procedures, and the implementation of non-pharmacological techniques. Conclusions. PS related safety and effectiveness are determined by the circumstances and professional skills rather than by specific pharmacologic characteristics. Evidence based recommendations regarding necessary skills and competence should be used to set up training programs and to define which professionals can and cannot be credentialed for PS in children.

Efficacy and safety of procedural sedation with propofol in a country with a young emergency medicine training program

Results 386 patients were enrolled over 18 months. The median age was 57 (IQR 38-70) years, 55% were male. All had ASA class score ≤ 3. Indications for procedural sedation were reduction of dislocations (52%), electro-cardioversion (32%), fracture reduction (9%) and abscess/wound treatment (6%). The median propofol dose was 1.0 mg/kg (0.70-1.5) and 44% also received fentanyl; median dose 1 mcg/kg (0.6-1.3). Most had a Ramsay sedation score of 4 or 5 (54%). The procedural success rate was 99.5%. No serious adverse events were reported. Sedation events included; hypoventilation (11%), desaturation (5%), hypotension (3%) and bradycardia (1%), all of which resolved with simple supportive interventions. One patient vomited without aspirating. Increased age (p = 0.001) and high Ramsey score (> 3) (p = 0.024) were the only significant predictors of events. Gender, weight, total dose of propofol, use of fentanyl and type of procedure were not independent risk factors for any event. Conclusion Procedural sedation with propofol can be performed safely and effectively by newly trained Dutch emergency physicians. Increased age and high Ramsay scores were the only risk factor for sedation events. All events were minor and responded to simple interventions. Possibly this study can aid the introduction of procedural sedation with propofol by emergency physicians in other countries where emergency medicine is a new and upcoming specialty.

Safety of procedural sedation and analgesia in children less than 2 years of age in a pediatric emergency department

BackgroundAlthough young age is considered a risk factor for adverse events related to procedural sedation and analgesia (PSA), data in very young children (<2 years of age) are lacking.AimsThe main objective of our study is to describe PSA in children <2 years of age in an inner city tertiary care pediatric emergency department (PED).MethodsWe conducted a retrospective chart review from January 2005 to June 2007 of children <2 years of age who received PSA in our PED. We collected demographic variables, indication for and medications used for PSA, adverse events (AE) related to PSA, and interventions performed to treat them.ResultsOf the children who received PSA, 14.5% (180/1,235) were <2 years of age of whom 173 were included for the analysis; 73% (126/173) of the study subjects were between 1 and 2 years of age, 54.3% (94/173) were male, and 96.5% (167/173) belonged to American Society of Anesthesiologists class 1. Incision and drainage (45.0%, 78/173) and laceration repair (32.4%, 56/173) were the two most common indications for PSA. Ketamine and midazolam was the most common combination medication used for PSA (62.4%, 108/173). Sedation was deemed ineffective in 5.8% (10/173) of the children. There were only two failed sedations; 5.8% (10/173) of the children experienced AE with most being minor [oxygen desaturations 1.7% (3/173), emesis 2.3% (4/173), and others 1.2% (2/173)]. One child experienced serious AE in the form of apnea and bradycardia requiring intubation.ConclusionsOur data suggest that children under 2 years of age can be sedated effectively without increased risk of AE in a PED.

Emergency department procedural sedation and analgesia: A Canadian Community Effectiveness and Safety Study (ACCESS)

To determine the effectiveness and safety of procedural sedation and analgesia (PSA) in a Canadian community emergency department (ED) staffed primarily by family physicians and to assess the role of capnometry monitoring in PSA. One hundred and sixty (160) consecutive procedural sedation cases were reviewed from the ED of a rural hospital in Huntsville, Ont. The ED is mainly staffed by family physicians who have received in-house training in PSA. Safety and effectiveness measures were extrapolated from a standardized PSA form by a blinded research assistant. The mean age of the patient population was 33.6 years (standard deviation = 23.6). Fifty-four percent of the patients were male, and 33% of the cases were pediatric. PSA medications included propofol (84%), fentanyl (51%) and midazolam (15%), and the procedural success rate was 95.6%. The adverse event (AE) rate was 18% and included apnea (10%), inadequate sedation (3%), bradycardia (2%), desaturation (1%), hypotension (1%) and bag-valve-mask use (1%). In those aged > or = 65 years there was a greater incidence of apnea. There were no episodes of emesis and there were no intubations. A modified jaw thrust manoeuvre was used in 23% of the cases. I the 64% of cases where capnometry was used, there was no association between its use and any AE measures. Procedural sedation was safe and effective in our environment. Capnometry recording did not appear to alter outcomes, although the data are incomplete.

Sedation and analgesia for procedures outside the operating room in children

There has been a dramatic increase in the number of procedures that are conducted in children in which sedation is now considered beneficial. In many institutions, however, resources and personnel have not been recruited to address this increase in demand. In most institutions, anaesthesiology departments are not able to provide anaesthesia for all procedures that are performed outside the operating theatre, and alternative solutions are needed. Recent research includes attempts to decrease the time required to induce sedation and to recover from it, and development of new organizational models to improve the safety of procedural sedation.

Safety of Pediatric Sedation by Non-Anesthesiologists

The JCAHO has placed renewed emphasis on the safety of procedural sedation (formerly called conscious sedation), and both the American Society of